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Double-Masked Study of Photrex (Rostaporfin) Photodynamic Therapy in the Treatment of Age-Related Macular Degeneration

This study is currently recruiting participants.
Verified by Miravant Pharmaceuticals, November 2005

Sponsored by: Miravant Pharmaceuticals
Information provided by: Miravant Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00157976
  Purpose

The purpose of this study is to confirm the efficacy and safety of rostaporfin (PHOTREX) photodynamic therapy (PDT) in the treatment of classic and occult subfoveal choroidal neovascularization (CNV) associated with age-related macular degeneration (AMD).


Condition Intervention Phase
Macular Degeneration
Drug: Photrex (rostaporfin)
Phase III

Genetics Home Reference related topics:   X-linked juvenile retinoschisis   

MedlinePlus related topics:   Macular Degeneration   

ChemIDplus related topics:   Rostaporfin   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study
Official Title:   A Phase III Randomized, Multicenter, Multinational, Double-Masked, Placebo-Controlled Study of Photrex (Rostaporfin) Photodynamic Therapy in the Treatment of Classic and Occult Subfoveal Choroidal Neovascularization Associated With AMD

Further study details as provided by Miravant Pharmaceuticals:

Primary Outcome Measures:
  • Visual Acuity

Secondary Outcome Measures:
  • Angiographic changes

Estimated Enrollment:   660
Study Start Date:   September 2005

  Eligibility
Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

Patients with age greater than or equal to 50 years with at least one subfoveal CNV membrane secondary to AMD that can be demonstrated by fluorescein angiography.

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00157976

Contacts
Contact: Miravant Pharmaceuticals     1-800-685-2959     ctinfo@miravant.com    

Locations
Bulgaria
Multiple Investigators     Recruiting
      Sofia, Bulgaria
Czech Republic
Multiple Investigators     Recruiting
      Brno-Bohunice, Olomouc, Praha, Czech Republic
Poland
Multiple Investigators     Recruiting
      Warsaw, Bydgoszcz, Lubin, Poland
Romania
Multiple Investigators     Recruiting
      Bucharest, Romania

Sponsors and Collaborators
Miravant Pharmaceuticals

Investigators
Study Director:     Wendy J. Snyder, PhD     Miravant Pharmaceuticals    
  More Information


Study ID Numbers:   MRVT-920101-OPH005
First Received:   September 8, 2005
Last Updated:   November 29, 2005
ClinicalTrials.gov Identifier:   NCT00157976
Health Authority:   United States: Food and Drug Administration;   Bulgaria: Bulgarian Drug Agency;   Czech Republic: State Institute for Drug Control (SUKL);   Poland: National Medicines Agency;   Romania: National Medicines Agency

Keywords provided by Miravant Pharmaceuticals:
Macular Degeneration  
AMD  
Visual Acuity  

Study placed in the following topic categories:
Metaplasia
Eye Diseases
Choroid Diseases
Retinal Degeneration
Macular Degeneration
Neovascularization, Pathologic
Retinal Diseases
Retinal degeneration
Choroidal Neovascularization

Additional relevant MeSH terms:
Uveal Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 10, 2008




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